Application 075273

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	KETOCONAZOLE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075273-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL			1999-06-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	4baebcab-a237-42c0-9183-6f447a44e371	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	a878a39d-6d26-4ede-9667-b3e201ffc337	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	2025-10-24	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	65dd4435-99f2-4383-b307-ba5bce9f1ca9	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	REMEDYREPACK INC.	ea56cddf-94c9-46b6-8791-995b741cfbd7	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Ketoconazole	KETOCONAZOLE CREAM, 2%	Encube Ethicals, Inc.	59188ef7-5bc9-4acc-bbff-8712c41e5f77	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	8ca815a8-bccb-4ee2-a042-922373329cae	2025-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Nizoral	KETOCONAZOLE	Kramer Laboratories	f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88	2025-08-21	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	A-S Medication Solutions	750bcfc3-b0e4-407e-ad12-e81b183f3b00	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Nizoral	KETOCONAZOLE	Kramer Laboratories	8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6	2025-07-11	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	3e3cde4b-939f-4837-9920-bb6bb8416bd6	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Amici Pharma Inc.	369f31da-d3c3-49b8-956f-f70598760164	2025-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	39d31bed-9caa-41bb-afdb-25fc18609c14	2025-04-24	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	a884bad7-df8c-45de-8c4f-42034b40e425	2025-04-23	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Tagrit Antifungal Treament Ketoconazole 1%	KETOCONAZOLE	TAGRID LLC	315a8832-c42f-c07a-e063-6394a90a8218	2025-03-27	Warnings	Name fallback generic name: KETOCONAZOLE
1% ketoconazole	KETOCONAZOLE	TAGRID LLC	30b75584-3a1e-c125-e063-6294a90acaa7	2025-03-19	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Zydus Lifesciences Limited	c004ee91-558a-450b-9e4e-d11ab9d28054	2025-03-12		Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Cosette Pharmaceuticals, Inc.	2d7c8dd1-59b5-2645-e063-6394a90a5bda	2025-02-06	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0900	Ketoconazole	Ketoconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
68151-2713	Ketoconazole	Ketoconazole	Carilion Materials Management	ANDA	Current
68788-9117	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42970	ORIG	1999-06-15
18402	ORIG	1999-06-15
8592	ORIG	1999-06-15